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Cytosar-U Side Effects

Generic Name: cytarabine

Note: This document contains side effect information about cytarabine. Some of the dosage forms listed on this page may not apply to the brand name Cytosar-U.

For the Consumer

Applies to cytarabine: parenteral conventional cytarabine injection, parenteral conventional cytarabine powder for injection, parenteral liposomal cytarabine injection

Side effects include:

IV, sub-Q, or IM administration of conventional cytarabine (the active ingredient contained in Cytosar-U) Myelosuppression, anorexia, nausea, vomiting, diarrhea, oral and anal inflammation or ulceration, hepatic dysfunction, fever, rash, thrombophlebitis, bleeding (all sites).

Intrathecal administration of conventional cytarabine: Nausea, vomiting, fever, transient headaches.

Intrathecal administration of liposomal cytarabine: Chemical arachnoiditis (neck rigidity, neck pain, meningism, nausea, vomiting, headache, fever, back pain, and/or CSF pleocytosis), asthenia, pain, confusion, somnolence.

For Healthcare Professionals

Applies to cytarabine: injectable powder for injection, injectable solution

Ocular

Very common (10% or more): Hemorrhagic conjunctivitis, corneal disorder
Common (1% to 10%): Photophobia, burning, visual disturbance, increased lacrimation, keratitis
Uncommon (0.1% to 1%): Conjunctivitis
Frequency not reported: Blindness[Ref]

Nervous system

Very common (10% or more): Somnolence
Common (1% to 10%): Decreased level of consciousness, dysarthria, nystagmus
Uncommon (0.1% to 1%): Neurotoxicity, neuritis, dizziness, headache, peripheral neuropathy, paraplegia (with intrathecal administration)
Frequency not reported: Dizziness, neurotoxicity rash, coma, convulsion, peripheral sensory neuropathy, ataxia, tremor, coma, convulsions[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Chest pain
Very rare (less than 0.01%): Arrhythmia
Frequency not reported: Pericarditis, cardiomyopathy[Ref]

Hematologic

Very common (10% or more): Bone marrow failure, thrombocytopenia, anemia, megaloblastic anemia, leukopenia, reticulocyte count decreased
Common (1% to 10%): Bleeding (all sites), thrombophlebitis
Frequency not reported: Reticulocytopenia, neutropenia, febrile neutropenia[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Anaphylactic reaction, allergic edema[Ref]

Immunologic

Very common (10% or more): Sepsis, infection
Frequency not reported: Viral, bacterial, fungal, parasitic, or saprophytic infections, in any location in the body (sometimes fatal)[Ref]

Local

Uncommon (0.1% to 1%): Injection site cellulitis, injection site thrombophlebitis
Frequency not reported: Injection site pain, injection site inflammation, injection site irritation, injection site sepsis[Ref]

Musculoskeletal

Very common (10% or more): Cytarabine (the active ingredient contained in Cytosar-U) syndrome (e.g., fever, myalgia, bone pain, occasionally chest pain, exanthema, maculopapular rash, conjunctivitis, nausea, malaise)
Uncommon (0.1% to 1%): Myalgia, joint pain[Ref]

Metabolic

Common (1% to 10%): Anorexia, hyperuricemia[Ref]

Psychiatric

Frequency not reported: Personality change, confusion[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary retention
Frequency not reported: Amenorrhea, azoospermia[Ref]

Hepatic

Very common (10% or more): Hepatic function abnormal
Common (1% to 10%): Liver enzymes increased
Uncommon (0.1% to 1%): Jaundice
Frequency not reported: Liver abscess, hyperbilirubinemia, hepatomegaly, Budd-Chiari-syndrome (hepatic venous thrombosis)[Ref]

Respiratory

Very common (10% or more): Pneumonia, acute respiratory distress syndrome, pulmonary edema
Uncommon (0.1% to 1%): Shortness of breath[Ref]

Other

Very common (10% or more): Pyrexia[Ref]

Renal

Uncommon (0.1% to 1%): Renal dysfunction[Ref]

Dermatologic

Very common (10% or more): Alopecia, rash
Common (1% to 10%): Skin ulceration, erythema, bullous dermatitis, vasculitis
Uncommon (0.1% to 1%): Lentigo, palmar-plantar erythrodysesthesia syndrome, urticaria, pruritus, freckling, burning pain of palms and soles
Very rare (less than 0.01%): Neutrophilic eccrine hidradenitis
Frequency not reported: Skin bleeding[Ref]

Gastrointestinal

Very common (10% or more): Stomatitis, mouth ulceration, anal ulcer, anal inflammation, diarrhea, vomiting, nausea, abdominal pain
Common (1% to 10%): Necrotizing colitis
Uncommon (0.1% to 1%): Sore throat, esophagitis, esophageal ulceration, bowel necrosis
Frequency not reported: Pancreatitis, bowel necrosis, GI ulcer, pneumatosis intestinalis, peritonitis, mucosal bleeding[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Cytarabine (cytarabine)." Hospira Inc, Lake Forest, IL.

Some side effects of Cytosar-U may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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